(125 days)
The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician). The AliveCor Heart Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and it is not intended for pediatric use.
The AliveCor Heart Monitor (the device) is the next generation of trans-telephonic (transmission by telephone) ECG (electrocardiogram) event recorders. The device utilizes the processing power of a mobile computing platform (MCP) while reducing the complexity of the electronics hardware associated with data acquisition and transmission. The AliveCor Heart Monitor can also analyze ECG signals and indicate the presence of noise, normal sinus rhythm and atrial fibrillation for each ECG recording.
Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the AliveCor Heart Monitor:
Note: The provided document is a 510(k) summary, which often provides less detailed information about specific study designs and acceptance criteria than a full clinical study report. Therefore, some information might be missing or inferred.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state the acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity thresholds) for atrial fibrillation or normal sinus rhythm detection. It generally states that "the collective results of the non-clinical testing demonstrate that the AliveCor Heart Monitor meets the established specifications necessary for consistent performance for its intended use."
However, it does reference AAMI/ANSI EC57: 2012 Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms. This standard typically outlines performance requirements for such algorithms, implying that the acceptance criteria would align with those specified in EC57. Without the full study report, the exact numerical thresholds for sensitivity and specificity are not available.
| Performance Metric | Acceptance Criteria (Inferred from EC57 & Document) | Reported Device Performance |
|---|---|---|
| Atrial Fibrillation Detection | (Likely sensitivity & specificity thresholds as per AAMI/ANSI EC57: 2012) | "validate the algorithms' performance" using EC57-recommended databases and captured data. (Specific performance values not provided in this summary) |
| Normal Sinus Rhythm Detection | (Likely sensitivity & specificity thresholds as per AAMI/ANSI EC57: 2012) | "validate the algorithms' performance" using EC57-recommended databases and captured data. (Specific performance values not provided in this summary) |
| Noise Detection | (Functionality as per device description) | "analyze ECG signals and indicate the presence of noise" |
| Overall Functionality | Meets established specifications for consistent performance | "the collective results of the non-clinical testing demonstrate that the AliveCor Heart Monitor meets the established specifications necessary for consistent performance for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The databases recommended by EC57 and data captured from the AliveCor Heart Monitor were used to validate the algorithms' performance."
- Sample Size for Test Set: Not explicitly stated. The EC57 standard recommends specific databases, but the exact number of ECGs used from these databases for validation is not provided in this summary.
- Data Provenance:
- Country of Origin: Not specified for the EC57 recommended databases. For "data captured from the AliveCor Heart Monitor," the country of origin is not specified, but the applicant is US-based.
- Retrospective or Prospective: Not explicitly stated. Database usage often implies retrospective data. "Data captured from the AliveCor Heart Monitor" could be either, but given the context of algorithm validation, it's likely a pre-existing dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. When leveraging external databases like those recommended by EC57, the ground truth is typically established by expert cardiologists; however, the number and their specific qualifications are not detailed here.
4. Adjudication Method for the Test Set
The adjudication method is not specified in the 510(k) summary. If external databases were used, the ground truth within those databases would have been established through a documented adjudication process by the creators of those databases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human readers improving with or without AI assistance was not mentioned in this 510(k) summary. This submission appears to be focused on the standalone performance of the device's algorithms.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance study of the algorithm was done. The document explicitly states: "The non-clinical testing included... algorithm validation to demonstrate... the performance of the algorithms." The indications for use also state the device "detects the presence of atrial fibrillation and normal sinus rhythm," implying automated detection.
7. The Type of Ground Truth Used
The ground truth was based on expert consensus embedded within the "databases recommended by EC57" and "data captured from the AliveCor Heart Monitor." For rhythm analysis, this typically means human experts (cardiologists or electrophysiologists) manually reviewed and annotated the ECGs to establish the true rhythm diagnosis (e.g., atrial fibrillation, normal sinus rhythm).
8. The Sample Size for the Training Set
The sample size for the training set is not explicitly stated in this 510(k) summary. The document focuses on the validation of the algorithms, which uses a separate test set.
9. How the Ground Truth for the Training Set Was Established
The method for establishing ground truth for the training set is not explicitly stated in this 510(k) summary. It's generally assumed that similar methods to the test set (expert consensus) would have been used for training data, but no details are provided here.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).